Process Expert Sterile Production - Visp (Maternity Cover) e/v/e/r/y/o/n/e

ten23 health; Oberwallis; On-site; CHF 120,000 - 180,000; Full time

Benefits offered by this job

Career development

Flexible work

Mentorship

Training options

Pension plan

Annual bonus

Job summary

ten23 health seeks a Process Expert in Visp to drive aseptic manufacturing processes for sterile parenteral products. You will oversee process data evaluation, CAPA-driven improvements, and cross-functional collaboration to ensure compliant, robust production.

The role requires deep expertise in fill-finish, filtration, and lyophilization, with strong GMP knowledge and audit experience. Start Jan 1, 2027, through Aug 31, 2027, on-site in Visp, Switzerland.

Qualifications

• University degree in Pharmacy, Biotechnology, Chemistry, Process or Mechanical Engineering, or a related technical/natural science.
• At least 5+ years in sterile pharmaceutical manufacturing with deep knowledge of fill-finish, filtration, and lyophilization.
• In-depth understanding of EU-GMP Annex 1, FDA 21 CFR 210/211, and ISO cleanroom standards with experience in inspections/audits.
• Strong experience in aseptic techniques, validation, and qualification with statistical methods and modern data analysis tools.
• Highly structured thinker with the ability to conduct root-cause analyses and make data-driven decisions.
• Excellent communication skills in German and English for cross-functional guidance.
• A resilient, responsible professional balancing teamwork with high quality manufacturing processes.

Responsibilities

• Serve as SME for aseptic manufacturing processes (filtration, filling, sterilization, VHP).
• Provide scientific support for transfer of new products into manufacturing.
• Investigate complex deviations with root-cause analyses and track CAPAs.
• Troubleshoot shopfloor issues and coach staff on GMP practices.
• Author/maintain process documentation, SOPs, and change evaluations.
• Support equipment, cleanroom and system qualifications; oversee validations.
• Conduct CPP/CQAs trend analyses to identify risks and inform decisions.
• Represent technical topics during audits and inspections.

Skills

Aseptic manufacturing

Root-cause analysis

Data analysis

Cross-functional communication

GMP compliance

Education

University degree in Pharmacy/related science

Tools

Statistical analysis tools

Industry-standard QA/QC tools

Job description

About Us

ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.

Your mission

Visp I Full-time | Start 1st Jan 2027 until 31st August 2027 As the Process Expert you are responsible for the process & compliance support, optimization, and continuous improvement of processes used in the manufacturing of sterile parenteral products. This role includes operational oversight of aseptic production steps as well as the scientific and technical evaluation of process data, changes, and deviations. The position holder is a recognized subject matter expert in aseptic manufacturing, supporting Production and Quality Assurance and ensuring robust, compliant, and efficient manufacturing processes. Your responsibilities will include:

• Serve as the subject matter expert for aseptic manufacturing processes (e.g., filtration, filling, sterilization, VHP), continuously evaluating and optimizing parameters, equipment, and workflows.
• Provide scientific and technical support for the seamless transfer of new products and processes into manufacturing.
• Independently investigate complex deviations in the aseptic environment using structured root cause analyses to define and track sustainable CAPAs.
• Actively troubleshoot technical issues directly on the shopfloor while coaching production personnel on aseptic best practices and strict GMP compliance.
• Author, review, and maintain critical process documentation, including risk assessments, SOPs, manufacturing records, and the technical evaluation of process-related changes.
• Support equipment, cleanroom, and system qualifications, and actively oversee validation protocols, including media-fill studies and aseptic process simulations.
• Conduct statistical evaluations and trend analyses of critical process parameters (CPPs) and quality attributes (CQAs) to proactively identify risks and provide input for PQR/APR.
• Act as the primary technical representative during internal and external audits, ensuring documentation is audit-ready and clearly presenting complex technical rationales to inspectors.

Your profile

We are looking for someone with:

• University degree in Pharmacy, Biotechnology, Chemistry, Process or Mechanical Engineering, or a related technical/natural science.
• At least 5+ years of professional experience in sterile pharmaceutical manufacturing, with deep technical knowledge of fill-finish technology, filtration, and lyophilization.
• In-depth understanding of EU-GMP Annex 1, FDA 21 CFR 210/211, and ISO cleanroom standards, including proven experience representing technical topics during inspections and customer audits.
• Strong experience in aseptic techniques, validation, and qualification, supported by a command of statistical methods and modern data analysis tools.
• Highly structured thinker with a strong technical affinity, capable of conducting root-cause analyses and making independent, data-driven decisions.
• Excellent communication skills in German and English, with the ability to translate complex technical concepts into clear, actionable guidance for cross-functional teams.
• A resilient and responsible professional who balances a team-oriented approach with a high-quality mindset to ensure robust and compliant manufacturing processes.

Why us?

We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential. Here's what sets ten23 apart:

• A valuable and impactful career development opportunity in an inspiring environment
• Flexible working arrangements and environment with an open culture and diverse workforce
• The opportunity to work with and learn from highly qualified and experienced employees
• Our learning and self-developing culture offers a wide range of training options
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit

At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.

Contact

For more information and clarification, please connect Amrith ([e-mail]) from our Talent team!